When a patient is administered a drug, the patient generally produces a response that is perceptible to the patient. For example, when a subject is experiencing pain, the subject will take a medication to relieve the pain symptoms. By effectively detecting and measuring the patient response, information regarding the effectiveness of the drug can be obtained and evaluated. An example of this includes analgesic potentiation. “Analgesic potentiation” is a type of pharmacologic activity that occurs when greater analgesic effectiveness is measured in patients treated with an analgesic drug combined with a non-analgesic ingredient than in patients treated with the analgesic drug alone. There are many reasons for the potentiation of an analgesic. For example, it would be desirable to enhance the clinical outcome for the patient (i.e., analgesic effectiveness). It would also be desirable to reduce the dosage of the analgesic (i.e., “optimal dose”) that is administered in view of possible side effects exhibited by the same or higher dose of the analgesic (i.e., “optimal analgesia,” a reduction of the risk:benefit ratio). It would also be desirable to provide greater pain relief or faster onset of pain relief. It would also be desirable to provide a longer duration, which results in less frequent dosing and better compliance. Finally, if the analgesic can improve one or more qualities of pain or one or more bodily functions of the patient or provide definite improvement of the patient, which will be discussed in greater detail below, these would be added benefits.
The measurement instruments for these overall effects are standard methods for determining general patient response such as analgesic activity. In the evaluation of analgesic potentiation, for example, clinical investigators by convention utilize these methods to demonstrate, to a statistically significant degree, that a combination of drugs provides “greater reduction in pain intensity” and “more pain relief” than the single-ingredient analgesic. However, conventional methods may not be able to demonstrate that a combination of the analgesic with another drug provides analgesic effectiveness to a greater extent than the analgesic alone. Measuring these conventional overall endpoints (i.e., “pain” and “relief”) may obscure specific clinical benefits that are meaningful to the patient and analgesic potentiation due to the presence of an additional drug or ingredient used in combination with the analgesic.
Thus, what are needed are methods for increasing or enhancing the measurement of patient responses. These methods could be used to demonstrate what is otherwise non-demonstrable using conventional methods.